FDA inspection

McLean Hospital Institutional Review Board: FDA inspection ending May 9, 2013

FDA inspection 828662 · Voluntary Action Indicated (VAI) · Belmont, MA

Key facts

Inspection ID 828662
Firm McLean Hospital Institutional Review Board
FEI number 1281969
Address 115 Mill St
City Belmont
State MA
ZIP 02478
Country United States
Fiscal year 2013
Inspection end date May 9, 2013
Classification Voluntary Action Indicated (VAI)
Project area Bioresearch Monitoring
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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